Regulatory Affairs Lead

Your Responsibilities:
Our mission at GSK is to improve the quality of lives by enabling people to do more, feel better and live longer. We recognise this starts with our own highly talented team and are committed to supporting, rewarding & developing our employees within a safe, supportive and inspiring work place.

Reporting into the Head of Regulatory Affairs (AU & NZ), this is a varied role that will see you engaging with a broad range of external and internal stakeholders in the GSK global and regional networks. As a critical member of our highly engaged and high achieving Regulatory Affairs team you will proactively monitor and shape the external environment to develop a positive regulatory environment that aligns with GSK's strategic business plans.

Your responsibilities will be broad and will include:
• Providing leadership, coaching and training support for the Regulatory Affairs team to impart your knowledge of best practice methodology and processes and to build technical and functional capability.
• The preparation, submission and tracking of accurate and timely regulatory applications.
• Assisting with the development and implementation of global GSK regulatory strategy.
• The management of maintenance of registered products ensuring product compliance.
• Working closely with local brand teams and global groups to proactively manage and where appropriate create, the response to all regulatory questions received from the Australian Regulatory Authorities (TGA) and Medsafe (NZ) within an agreed priority and timeframe.
• To provide input and expertise to assist medical, commercial, market access and marketing teams with new product initiatives and activities.

To be successful in this role you will have:
• A degree in pharmacy, chemistry, immunology or pharmacology with a strong preference for post graduate studies.
• First-hand experience with major regulatory submissions in Australia essential (NZ experience desirable).
• Therapeutic/scientific experience in one or several of the following: vaccines; respiratory; HIV; oncology
• Experience and subject matter expertise in regulatory affairs within the pharmaceutical industry specifically for prescription rather than generic medicines.
• Exceptional written and verbal communication skills with the ability to foster positive and proactive relationships with a broad range of stakeholders including the TGA, Industry Associations and a broad range of internal stakeholders.
• Excellent time management and prioritisation skills
• Strong analytical skills, excellent attention to detail and a commitment for compliance processes.
• Ability to think strategically and innovatively for resolution of regulatory issues.
• People management skills desirable
This role represents a great opportunity to work in an innovative global pharmaceutical company within a close-knit and engaged team working on a large pipeline of prescription products.

Why You?

Basic qualifications:
A degree in pharmacy, chemistry, immunology or pharmacology.

Preferred qualifications:
Strong preference for post graduate studies.

Why GSK?:
GlaxoSmithKline (GSK) is an innovative global leader in pharmaceutical research and development with a long and proud history in Australia. Our Australian, Melbourne-based business consists of both Pharmaceuticals and Vaccines.

Contact information:
You may apply for this position online by selecting the Apply now button.
Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.


Meet Some of GlaxoSmithKline's Employees

Jasdeep

Procurement Associate

Jasdeep finds diverse suppliers to build GSK’s pipeline. He organizes joint ventures with companies and negotiates pricing rates and payments to build a seamless supply system for GSK’s materials and products.

Andrea

HR Associate, Future Leaders Program

Now in her second rotation of GSK’s Human Resources Future Leaders Programme, Andrea is shaping the future of talent management within Research and Development, from workforce assessments to strategy and operations.


Back to top